Equinus Foot Deformity in Children With Cerebral PalsyPerLENCT02856321
PerLE (Peroneus Longus Evaluation): A Study Evaluating the Efficacy of Injection of Dysport in Peroneus Longus in Equinus Foot Deformity in Children With Cerebral Palsy
An observational study of Equinus Foot Deformity in Children With Cerebral Palsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
A recent publication (Boulay et al. 2012) highlighted the role of the peroneus longus (PL) muscle in equinus foot deformity in children with hemiplegia. BoNT (Dysport) injections into this muscle have not yet been described in the literature. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Equinus Foot Deformity in Children With Cerebral Palsy
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: children with cerebral palsy (hemiplegia or diplegia) which have been treated by BoNT (Dysport) intramuscular injections into PL in the service between 2007 and July 2012 .
Who may be able to join
- Children between 2 and 6 years of age with cerebral palsy treated by intramuscular injection of BoNT (Dysport) into the PL (only) between 2007 and 2012.
- At least one BoNT (Dysport) injection performed into PL only
- Hemiplegic or diplegic subjects
- Dynamic equinus with hindfoot valgus with a documented premature onset activity of the peroneus longus which occurred earlier than the onset of Gastrocnemius Medialis (GM) activity, during terminal SW (i.e. EMG background data available).
- Evaluation based on Gross Motor Function Classification System (GMFCS ≤ 2) performed for children aged to 6-12 years (i.e available in the subject's medical folder).
- Feet Xrays data available before the first injection of BoNT (Dysport) and after for each subject
- Pre- and post-BoNT (Dysport) injection radiological data available in the subjects's medical folder
Who cannot join
- Equinus deformity due to a triceps surae contracture and a limb length discrepancy over 1 cm.
- Other muscle than PL injected with BoNT (Dysport) during the evaluation period (between the pre- ant post-BoNT (Dysport) radiological evaluation)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Timone
Marseille, 13354
Christophe BOULAY, 0491384216, christophe.boulay@ap-hm.fr
About this study
A recent publication (Boulay et al. 2012) highlighted the role of the peroneus longus (PL) muscle in equinus foot deformity in children with hemiplegia. BoNT (Dysport) injections into this muscle have not yet been described in the literature. Based on the results of a previous study, the hypothesis is: this muscle may thus constitute a new therapeutic target for botulinum toxin injections in the early management of spastic equinus in children aged 2 years or older, before the onset of fixed neuro-orthopedic deformity and the midfoot break.
The aim of this retrospective study is to describe in intramuscular BoNT (Dysport) injections into PL based on the results obtained in a cohort of children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) and which have been treated in the service since 2007 until July 2012.
Read more
The investigators results are based on clinical, radiological and video evaluations. For this study, data will be collected in medical folder of each children belonging to this cohort.
All children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) which have been treated by BoNT (Dysport) intramuscular injections into PL in the service between 2007 and July 2012 will be screened. Subjects will be selected according to the following defined inclusion and exclusion criteria.
Data will be collected retrospectively (using a specific case report form designed for the study) in medical folder of each included subject for all visit of follow-up after BoNT (Dysport) injection into PL (since the first BoNT (Dysport) injection up to 2012). Then, data will be entered in a database. After that, they will be analysed .
What is being measured
The primary outcome is the main question the study is designed to answer.
foot morphology variation
radiological foot parameters including measured forefoot pronation (metatarsal stacking angle), midfoot planus (lateral talo-first metatarsal or Meary angle) and equinovalgus hind foot (incidence of postero-anterior ankle, calcaneal pitch and talocalcaneal angles)
Measured: 3 months
Secondary outcomes (6)
age
year
Measured: 3 months
sex
female or male
Measured: 3 months
weight
Measured: 3 months
Body Mass Index (BMI)
Measured: 3 months
Percentage of premature onset of muscle activity (EMG)
Measured: 3 months
Radiological data
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Equinus Foot Deformity in Children With Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856321
- Sponsor's protocol ID
- 2014-52
- Acronym
- PerLE
- Status last verified
- Jul 2016
- First submitted
- 28 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PerLE (Peroneus Longus Evaluation): A Study Evaluating the Efficacy of Injection of Dysport in Peroneus Longus in Equinus Foot Deformity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02856321
- Acronym / sponsor ID
- PerLE / 2014-52
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A recent publication (Boulay et al. 2012) highlighted the role of the peroneus longus (PL) muscle in equinus foot deformity in children with hemiplegia. BoNT (Dysport) injections into this muscle have not yet been described in the literature. Based on the results of a previous study, the hypothesis is: this muscle may thus constitute a new therapeutic target for botulinum toxin injections in the early management of spastic equinus in children aged 2 years or older, before the onset of fixed neuro-orthopedic deformity and the midfoot break.
The aim of this retrospective study is to describe in intramuscular BoNT (Dysport) injections into PL based on the results obtained in a cohort of children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) and which have been treated in the service since 2007 until July 2012.
The investigators results are based on clinical, radiological and video evaluations. For this study, data will be collected in medical folder of each children belonging to this cohort.
All children (approximately 30 subjects) with cerebral palsy (hemiplegia or diplegia) which have been treated by BoNT (Dysport) intramuscular injections into PL in the service between 2007 and July 2012 will be screened. Subjects will be selected according to the following defined inclusion and exclusion criteria.
Data will be collected retrospectively (using a specific case report form designed for the study) in medical folder of each included subject for all visit of follow-up after BoNT (Dysport) injection into PL (since the first BoNT (Dysport) injection up to 2012). Then, data will be entered in a database. After that, they will be analysed .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with cerebral palsy (hemiplegia or diplegia) which have been treated by BoNT (Dysport) intramuscular injections into PL in the service between 2007 and July 2012 .
Key inclusion criteria (7 listed)
- Children between 2 and 6 years of age with cerebral palsy treated by intramuscular injection of BoNT (Dysport) into the PL (only) between 2007 and 2012.
- At least one BoNT (Dysport) injection performed into PL only
- Hemiplegic or diplegic subjects
- Dynamic equinus with hindfoot valgus with a documented premature onset activity of the peroneus longus which occurred earlier than the onset of Gastrocnemius Medialis (GM) activity, during terminal SW (i.e. EMG background data available).
- Evaluation based on Gross Motor Function Classification System (GMFCS ≤ 2) performed for children aged to 6-12 years (i.e available in the subject's medical folder).
Key exclusion criteria (2 listed)
- Equinus deformity due to a triceps surae contracture and a limb length discrepancy over 1 cm.
- Other muscle than PL injected with BoNT (Dysport) during the evaluation period (between the pre- ant post-BoNT (Dysport) radiological evaluation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
foot morphology variation
Time frame: 3 months
radiological foot parameters including measured forefoot pronation (metatarsal stacking angle), midfoot planus (lateral talo-first metatarsal or Meary angle) and equinovalgus hind foot (incidence of postero-anterior ankle, calcaneal pitch and talocalcaneal angles)
6 secondary outcomes
age
Time frame: 3 months
sex
Time frame: 3 months
weight
Time frame: 3 months
Body Mass Index (BMI)
Time frame: 3 months
Percentage of premature onset of muscle activity (EMG)
Time frame: 3 months
Radiological data
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
Related trials for Equinus Foot Deformity in Children With Cerebral Palsy
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EQUINUS DEFORMITY
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Equinus Foot Deformity in Children With Cerebral Palsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe BOULAY (0491384216, christophe.boulay@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
foot morphology variation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.